On (b)(6) 2016, the reporter contacted animas, alleging a power (intermittent power) issue.This complaint is being reported because the reported issue was not resolved with troubleshooting.There was no indication that the product caused or contributed to an adverse event.
|
Follow-up #1: date of submission 05/26/2016.Device evaluation: the device has been returned and evaluated by product analysis on 05/12/2016 with the following findings: the review of the black box showed multiple unexpected power reboots.The battery compartment was undamaged and the returned battery cap was able secure and maintain the electrical connection.The battery cap contact height and width measured within specifications.Additionally, the battery cap was fastened and then unscrewed half turn with no power reboot occurrences.The ez-prime steps were performed correctly with no power interruptions, errors, alarms or warnings.Upon removal of the pump cover, no intermittent condition was found to the power circuit or to the continuous glucose monitoring module.
|